SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease

ConditionDry Eye Disease (DED)

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorIndiana University

About this trial

This is a prospective, randomized, double-masked, multi-site clinical trial designed to compare the efficacy of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED). The primary goal is to determine whether SYSTANE® PRO is non-inferior to MIEBO™ after one month of treatment, based on change in Ocular Surface Disease Index (OSDI) scores.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults>=18 years of age

Corrected visual acuity of 20/100 or better in both eyes

Ocular Surface Disease Index [OSDI] scores between 23 and 50 units [inclusive]

Tear break up time score of <=5 seconds in both eyes

Disqualifiers

Discontinue contact lens wear starting 7 days prior and throughout the study

Artificial tears and warm compresses should not be used for at least one week prior to enrollment and throughout the study

Systemic health conditions that are known to alter tear film physiology(e.g., primary and secondary Sjogren's syndrome)

History of ocular surgery within the past 12 months

Trial design

Design model

Parallel

Treatments tested in this trial

SYSTANE® PRO
Drug
SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar.
MIEBO™ (Perfluorohexyloctane, PFHO)
Drug
Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.

Treatment groups

260 Participants

are divided into 2 treatment groups

Group A: SYSTANE® PROActive comparator 1 intervention

Group B: MIEBO™ (Perfluorohexyloctane, PFHO)Active comparator 1 intervention

Trial outcomes

Primary outcomes

OSDI Scores

Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 1-month visit (0-100 scale).

Time frame

Between group difference at 1 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Alcon Research

Collaborator

Source ClinicalTrials.gov

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